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Procedural SedationNCT07168135

Effect of Discontinuing Propofol After Cecal Intubation on Patient's Psychomotor Recovery Following Colonoscopy

A study testing propofol (drug) in people with Procedural Sedation and Colonoscopy, run by American University of Beirut Medical Center at 1 site in Lebanon.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study investigates whether discontinuing the continuous intravenous infusion of propofol immediately after cecal intubation would reduce the patient's recovery time without compromising their comfort or convenience. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
propofol (drug)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteLebanon
Study dates
19 May 2025to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 80 years.
  • Scheduled ambulatory elective screening or surveillance colonoscopy under MAC.

Who cannot join

  • Medical contraindication to anesthesia (i.e., respiratory/cardiac/neurologic compromise, known allergy or adverse reaction to propofol, midazolam, lidocaine, or opiates, …)
  • History of ischemic or hemorrhagic cerebrovascular accident.
  • Baseline cognitive dysfunction (impaired memory, attention deficit, language disorders, …) - in other words, any dysfunction that prevents the subject from understanding the study protocol and/or completing the requested tests and assessments (e.g., playing the minigames, …)
  • Use of more than one psychoactive drug.
  • History of partial colectomy.
  • Unable to give consent.

Trial locations and contacts

1 site in 1 country.

Lebanon1 site
  • The American University of Beirut Medical Center

    Beirut, 1107

Other trials in Lebanon

About this study

Official title: Effect of Discontinuing Propofol Anesthesia After Cecal Intubation on Patient's Psychomotor Recovery Following Colonoscopy: A Prospective Two-Arm Parallel Randomized Double-Blind Interventional Controlled Trial

This study investigates whether discontinuing the continuous intravenous infusion of propofol immediately after cecal intubation would reduce the patient's recovery time without compromising their comfort or convenience. It would also reduce procedural costs and the risk of medical hazards due to potentially excessive sedation.

Read the detailed description

Colonoscopy is usually conducted after inducing depression in the patient's level of consciousness through sedation, ranging from minimal anxiolysis to general anesthesia, to establish relief from potential anxiety, discomfort, and pain during the procedure; in addition to diminishing the patient's memory of the event and minimizing the risk of adverse events related to agitation. It is traditionally done under endoscopist-directed conscious sedation via the administration of a benzodiazepine and a narcotic. However, anesthesia-assisted sedation has significantly risen for the last decade using almost exclusively propofol continuous intravenous drip, with propofol being a non-analgesic sedating agent marked by its rapid distribution and elimination and stronger sedating effect than the standard regimen, leading to faster induction and recovery from sedation and higher physician and patient satisfaction rates. Several anesthesia techniques were also introduced to ease the visceral pain associated with colonoscopy, such as intravenous lidocaine infusion, low-dose intravenous ketamine, and inhalation of an anesthetic mixture of oxygen with nitrous oxide.

Nevertheless, procedural sedation can induce mild cognitive decline after seemingly full recovery. Padmanabhan and colleagues report a significant decrease in visual attention and psychomotor function from baseline after sedation for colonoscopy. It is recommended by the guidelines for conscious sedation and monitoring during gastrointestinal endoscopy (ASGE, 2003) and the Institute Review of Endoscopic Sedation (AGA, 2008) that patients should be accompanied home by a responsible individual after endoscopic sedation, in addition to be instructed to avoid driving, make legally binding decisions, or operate heavy or potentially harmful machinery. The investigators have recently shown that an important proportion of patients experience periods of general anesthesia and/or a deep hypnotic state during endoscopy.

Prolonged systemic anesthesia is noted to increase the risk for serious complications in colonoscopy patients, either hemodynamically or psychomotorly. Additionally, Wernli and colleagues showed that the overall risk of complications after colonoscopy within 30 days increases when individuals receive anesthesia services, namely, the increased risk of perforation, abdominal pain, and stroke. Thus, minimizing the time systemic anesthesia is administered to the patient as possible during the procedure will likely reduce its potential side effects.

The withdrawal time following cecal intubation is quite controversial and operator-dependent. However, it is recommended to be between 6 and 9 minutes. Thus, withholding anesthetic agents during this phase might be beneficial. It would reduce the patient's exposure to anesthesia without causing any significant under-sedation until the near end of the procedure. At the same time, this intervention may accelerate the patient's post-procedure psychomotor recovery by terminating systemic sedation at an earlier checkpoint. Moreover, Adenoma detection rate (ADR), which refers to the rate of detecting colonic adenomas, is typically assessed during the withdrawal of the scope after cecal intubation. It is well known that this rate is influenced by the withdrawal time, meaning the duration the colonoscopist spends withdrawing the scope from the patient. Early discontinuation of anesthesia could limit the time available for the colonoscopist to detect adenomas during withdrawal, making it a significant outcome to evaluate after each colonoscopy.

This study explores whether discontinuing the continuous intravenous infusion of propofol directly following cecal intubation would shorten the patient's recovery time without affecting his comfort or convenience. It would also reduce procedural costs and the risk of medical hazards due to potentially excessive sedation.

Being tested
propofol (drug)
Keywords
Cecal intubation, Psychomotor recovery, Procedural sedation, Colonoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • propofol (drug)Drug

    Withholding the continuous propofol intravenous drip upon intubating the cecum during the colonoscopy.

Study groups in NCT07168135
Study groupRoleWhat they receive
Propofol withdrawal armExperimentalThis group will undergo withholding of the propofol sedation upon intubating the cecum during the colonoscopy.
Receives: Drug: propofol (drug)
Propofol continuation armNo interventionThis group will not undergo propofol sedation stoppage upon intubating the cecum during the colonoscopy, and will continue receiving continuous intravenous propofol until the full withdrawal of the colonoscope.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to psychomotor recovery after the completion of the colonoscopy

    Measured: From enrollment until 24 hours after finishing the colonoscopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2025
  2. Study start19 May 2025
  3. Primary completionNov 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07168135
Sponsor's protocol ID
BIO-2024-0344
Status last verified
Sep 2025
First submitted
25 Aug 2025
Last updated
11 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • El Mokahal A, Daher HB, Yamout R, Hoshaimi N, Ayoub C, Shaib Y, Sharara AI. Randomized controlled trial of procedural sequence for same-day bidirectional endoscopy under monitored anesthesia care (RECoVER Trial). IGIE. 2023 Jul 25;2(3):282-291. doi: 10.1016/j.igie.2023.07.014. eCollection 2023 Sep.

    PubMed 41646987
  • Bou Daher H, El Mokahal A, Ibrahim MA, Yamout R, Hochaimi N, Ayoub C, Shaib YH, Sharara AI. General anesthesia and/or deep hypnotic state in propofol-based conscious sedation for endoscopy. IGIE. 2024 May 4;3(2):286-292. doi: 10.1016/j.igie.2024.04.017. eCollection 2024 Jun.

    PubMed 41647084
  • ASGE Standards of Practice Committee; Early DS, Lightdale JR, Vargo JJ 2nd, Acosta RD, Chandrasekhara V, Chathadi KV, Evans JA, Fisher DA, Fonkalsrud L, Hwang JH, Khashab MA, Muthusamy VR, Pasha SF, Saltzman JR, Shergill AK, Cash BD, DeWitt JM. Guidelines for sedation and anesthesia in GI endoscopy. Gastrointest Endosc. 2018 Feb;87(2):327-337. doi: 10.1016/j.gie.2017.07.018. Epub 2018 Jan 3. No abstract available.

    PubMed 29306520

Questions about this trial

What is this clinical trial studying?

A study testing propofol (drug) in people with Procedural Sedation and Colonoscopy, run by American University of Beirut Medical Center at 1 site in Lebanon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to psychomotor recovery after the completion of the colonoscopy (time frame: From enrollment until 24 hours after finishing the colonoscopy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07168135, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.

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